Orchestrate provides a MedTech quality and regulatory compliance platform that automates FDA 510(k), EU MDR, and UKCA submission workflows. The software handles device classification, predicate identification, and eSTAR document generation, reducing manual administrative work for medical device companies. It supports SaMD, hardware, and IVD products across low-to-moderate risk pathways.
Funding
Funding not disclosed
Founders
Product
Problem
MedTech companies face significant administrative burden from disconnected documents, manual cross-referencing, and time-consuming regulatory submission processes. These inefficiencies slow time-to-market and create compliance risks, particularly for companies navigating FDA 510(k), EU MDR, and UKCA pathways simultaneously.
Solution
Orchestrate provides a quality and regulatory compliance platform that automates the heavy lifting of regulatory submissions. The software analyzes device classification, identifies predicate devices, and generates submission documents in eSTAR format, covering FDA 510(k), EU MDR, and UKCA conformity assessments. With 98% automation coverage across 8 workflows, Orchestrate handles the administrative work so teams can focus on innovation while maintaining compliance. The platform supports Software as a Medical Device (SaMD), Class I & II hardware, and IVD products, with additional pathways for combination products and pharmaceutical submissions in development.
Target Audience
Primary customers are MedTech companies developing SaMD, medical device hardware, and IVD products that need to navigate FDA, EU MDR, and UKCA regulatory pathways efficiently.
Features
- Automated device classification and predicate device identification for FDA 510(k) submissions
- eSTAR package generation with 510(k) summaries, predicate comparisons, and performance data compilation
- 8 pre-built workflows covering FDA 513(g) requests, EU MDR technical documentation, and UKCA conformity assessments
- 98% automation coverage reducing manual document cross-referencing and admin overhead
- Support for SaMD, Class I & II hardware, and IVD Class A–C products
- Live submission tracking with action completion metrics and output status monitoring